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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 4-151
Standard
ISO 22112 First edition 2005-11-01
Dentistry - Artificial teeth for dental prostheses
U.S. Identical Adoption
ANSI ADA Standard No. 15-2008 (R2013)
Artificial Teeth for Dental Prostheses
Scope/Abstract
ISO 22112:2005 specifies the classification, requirements, and test methods for synthetic polymer and ceramic teeth that are manufactured for use in prostheses used in dentistry.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3590 Additively Manufactured, Preformed, Resin Denture Tooth Class 2 PZY
§872.3590 Denture, Plastic, Teeth Class 2 ELM
FDA Technical Contact
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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